Topotecan Episcleral Plaque for Treatment of Retinoblastoma (NCT04428879) | Clinical Trial Compass
CompletedPhase 1
Topotecan Episcleral Plaque for Treatment of Retinoblastoma
Canada26 participantsStarted 2020-06-16
Plain-language summary
This single site, single-arm, non-randomized, dose escalation phase I toxicity clinical trial will assess primarily the safety and secondarily the efficacy of episcleral topotecan in patients with active de novo or residual or recurrent intraocular retinoblastoma in at least one eye following completion of first-line therapy.
Who can participate
Age range17 Years
SexALL
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Inclusion criteria
✓. Age. Participants must be \<18 years of age.
✓. Diagnosis and Treatment. Participants must have: (i) active residual or recurrent intraocular retinoblastoma following completion of first-line therapy (chemotherapy, systemic or intra-arterial, focal therapy or brachytherapy), or (ii) unilateral Group B, C, D or cT1b, cT2 retinoblastoma at diagnosis with no previous treatment.
✓. One eye will be the Study Eye. When participants have two eyes with retinoblastoma, the eye with worst disease or best vision potential will be designated the Study Eye. There will only be one eye per child treated in this Phase I study, since treatment of two eyes would double the systemic dose of drug. The Non-study eye will be treated by standard of care, with only focal therapy during the Study Period, if required.
✓. Disease status. Study eye must have vision potential and no clinical features suggestive of high risk of extraocular extension.
✓. Performance status. Lansky play score ≥ 50 if \<16 years of age; Karnofsky performance scale of ≥ 50 if ≥16 years of age (Appendix I)
✓. Organ function:
✓. Adequate bone marrow function and platelet count
✓. Adequate renal function
Exclusion criteria
✕. Disease status. Participants known to have any of the following are excluded:
✕. clinical or EUA evidence of extraocular extension
What they're measuring
1
Maximum Tolerated Dose and Recommended Phase 2 Dose of topotecan hydrochloride administered as a Chemoplaque to pediatric patients with active Retinoblastoma.
. known metastatic disease status and intercurrent illness
✕. existing clinical and neuroimaging showing suspicion of, or definitive,
✕. Allergy. Participants with reported allergy to topotecan, camptothecin or derivatives thereof.
✕. Concomitant treatment. Participants may not receive chemotherapy or other focal retinoblastoma therapy or any other investigational agent within 3 weeks of the placement and removal of the Chemoplaque, nor while the Chemoplaque is in situ.
✕. Uncontrolled intercurrent illness. Participants with known uncontrolled intercurrent illness that, in the investigator's opinion, would put the participant at undue risk or limit compliance with the study requirements.
✕. Febrile illness. Participants with clinically significant febrile illness (as determined by the investigator) within one week prior to initiation of protocol therapy.